MannKind Closes Phase 3 Study of AFREZZA for Type 1 Diabetes

MannKind Corporation (Nasdaq: MNKD) today announced that all follow-up visits
have been completed for the patients enrolled in Study 171, a Phase 3 clinical
study of AFREZZA^® (insulin human [rDNA origin]) inhalation powder, an
investigational, ultra rapid-acting mealtime insulin therapy, administered
using MannKind's next-generation inhaler. MannKind expects to release data
from this study later this summer.

Study 171 is an open-label study in patients with type 1 diabetes. After a
run-in period, during which all patients were optimized on their basal insulin
regimen, 518 subjects were randomized to one of three arms for mealtime
insulin: a control arm, in which patients utilize injected rapid-acting
insulin, or one of two AFREZZA arms, one for the MedTone inhaler and the other
for the next-generation inhaler. After the mealtime insulin was titrated,
there was a 12-week observation period on stable doses of the mealtime insulin
to assess HbA1c levels, which is the primary outcome parameter. Another
objective of this study is to compare the safety profile of the two AFREZZA
treatment groups.